Occurrence of solicited local and general adverse events (AEs) [ Time Frame: During the 7 day follow-up period following each vaccination (day of vaccination and 6 subsequent days) ] [ Designated as safety issue: No ]

Occurrence of unsolicited AEs [ Time Frame: During the 30 day follow-up period following each vaccination (day of vaccination and 29 subsequent days) ] [ Designated as safety issue: No ]

Occurrence of all potential Immune-Mediated Disease(s) (pIMDs) [ Time Frame: During the entire study period (Day 0 to Month 7) ] [ Designated as safety issue: No ]

Occurrence of solicited local and general adverse events (AEs) [ Time Frame: During the 7 day follow-up period following each vaccination (day of vaccination and 6 subsequent days) ] [ Designated as safety issue: No ]

Occurrence of unsolicited AEs [ Time Frame: During the 30 day follow-up period following each vaccination (day of vaccination and 29 subsequent days) ] [ Designated as safety issue: No ]

Occurrence of all potential Immune-Mediated Disease(s) (pIMDs) [ Time Frame: During the entire study period (Day 0 to Month 7) ] [ Designated as safety issue: No ]

Evaluation of the Kinetics of mRNA Expression After Two Doses of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 in Healthy Adults

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of two doses of the TB vaccine administered according to a 0, 1 month schedule. In, addition, blood samples collected at different time points after vaccination will be analysed to see when exactly genes are activated by the vaccine using an assay called mRNA expression profiling. The different methods for mRNA expression profiling using whole blood samples versus Peripheral Blood Mononuclear cell(s) (PBMCs), will also be compared.

Detailed Description

Not Provided

Study Type ICMJE

Interventional

Study Phase

Phase 2

Study Design ICMJE

Endpoint Classification: Safety/Efficacy StudyIntervention Model: Single Group AssignmentMasking: Open Label

Condition ICMJE

Tuberculosis

Intervention ICMJE

Biological: GSK Biologicals' investigational TB vaccine GSK 692342

2 doses administered intramuscularly according to a 0, 1 month schedule (Day 0 and Day 30), in the deltoid region of the arm

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

A male or female between, and including, 18 and 50 years of age at the time of obtaining informed consent.

Written informed consent obtained from the subject.

Healthy subjects as established by medical history and clinical examination before entering into the study.

Known BCG vaccination or presence of a BCG scar.

Seronegative for human immunodeficiency virus-1.

Female of non-childbearing potential may be enrolled in the study.

Female subjects of childbearing potential may be enrolled in the study, if the subject:

has practiced adequate contraception for 30 days prior to vaccination, and

has a negative pregnancy test on the day of screening and the day of first vaccination, and

has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent). Inhaled and topical steroids are allowed.

Administration of long-acting immune-modifying drugs starting 2 years before the first dose and planned administration during the study.

Planned administration/administration of a vaccine/product not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending at the last study visit.

Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).

History of TB disease.

History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

QuantiFERON® TB Gold positive test result.

History of medically confirmed autoimmune disease.

Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

History of any reaction of hypersensitivity likely to be exacerbated by any component of the vaccine.

Pregnant or lactating female.

Female planning to become pregnant or planning to discontinue contraceptive precautions.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects